Sildenafil

Product NDC
70518-4596
11-digit product format
705184596
Labeler code
70518
Product ID
70518-4596_4dd848c1-958d-2d31-e063-6294a90a1ffd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202025
Marketing category
ANDA
Marketing start
2026-03-24
Substance
SILDENAFIL CITRATE
Active strength
20 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sildenafil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILDENAFIL CITRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui577033

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fabccea2-36c8-9268-ee44-ec231455538fProduct name920241217
ac996ae9-22a2-41c2-bb86-913c4aef95adProduct name120230606
fc95c9f0-00dc-40ef-bcea-b60c9009c5fcProduct name920220613

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4596-0Sildenafil250 in 1 BOXTABLET2501
70518-4596-1Sildenafil1 in 1 POUCHTABLET11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSNf5113b5e-9087-4397-86bc-5ea10413c4291
577033sildenafil 20 MG Oral TabletSCDf5113b5e-9087-4397-86bc-5ea10413c4291
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYf5113b5e-9087-4397-86bc-5ea10413c4291

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4596-070518459600250 POUCH in 1 BOX (70518-4596-0) / 1 TABLET in 1 POUCH (70518-4596-1) 250 pouch2026-03-24NoNoHistorical
70518-4596-1705184596011 in 1 POUCHHistorical